BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3192114 · Received June 20, 2013

    Report

    Report Number
    1627487-2013-04784
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    July 9, 2009
    Report Date
    May 29, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: 1627487-07262012-002-R. THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORIES. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2013-04785, 1627487-2013-04786. THE PATIENT RECEIVED 5 LEADS WITH TWO DIFFERENT LOT NUMBERS. IT WAS REPORTED THE PATIENT HAD NOT RECEIVED ADEQUATE STIMULATION SINCE SHE WAS IMPLANTED. THE PATIENT HAD NOT RECHARGED THE IPG FOR ABOUT 2 YEARS. IN ADDITION, THE PATIENT REPORTED SHE HAD A PERSISTENT PAIN AT THE IPG SITE. THE PATIENT HAD REQUESTED FOR THE SCS SYSTEM TO BE EXPLANTED, AND THE PHYSICIAN PLANNED SURGICAL INTERVENTION TO REMOVE THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280601 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2799145

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other SCS EXTENSION, MODEL 3341 (2)| IMPLANT DATE: